Safety and efficacy of percutaneous Inoue-balloon mitral commissurotomy

Although percutaneous transvenous mitral commissurotomy (PTMC) is currently accepted as the first-line treatment modality for selected patients with mitral stenosis, technical failures and the potential risk of inadvertent cardiac perforation with tamponade, resultant severe mitral regurgitation and death associated with the procedure continue to be important issues of concern.

The purpose of this study was to assess the safety profile and acute results of Inoue-balloon PTMC in a consecutive series of 50 patients with symptomatic significant mitral stenosis who underwent the procedure between January 1993 and August 1994.

PTMC was successfully completed in all patients without encountering cardiac perforation, cardioembolism, severe (> or = grade 3+) angiographic mitral regurgitation or death. The mitral valve area increased from 0.8 +/- 0.2 cm2 to 1.7 +/- 0.4 cm2 (p = 0.0001) as assessed echocardiographically. Optimal results defined as a valve area improvement of > or = 50% and/or a final valve area of > or = 1.5 cm2 without significant mitral regurgitation (> or = 2 grade increase in mitral regurgitation or a final regurgitation > or = 3+) was obtained in 94% of patients.

We confirm that Inoue-balloon PTMC is a safe and highly effective procedure as reflected by the absence of cardiac perforation, cardioembolism, severe mitral regurgitation or death and the excellent enlargement in mitral valve area. Furthermore, in our study the clinical restenosis rate was low with the majority of patients maintaining their improved functional status over a 14-month follow-up period.